top of page
Official regulatory classification and certification status for each device.
All PlasmoClean systems are independently tested and certified under international medical and safety standards to ensure full regulatory compliance and proven reliability.
classification
Product
Medical
devices
Devices classified as medical devices are developed and manufactured within a quality management system certified in accordance with Regulation (EU) 2017/745 (MDR), Annex IX Chapter I.
The certified quality management system is subject to conformity assessment and periodical surveillance by a notified body.
Electrical
devices
Devices classified as electrical devices are testet in accordance with applicable international electrical safety and electromagnetic compatibility standards, including IEC and CISPR frameworks.
Compliance is documented per device as listed below.
bottom of page